Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5856934 | Regulatory Toxicology and Pharmacology | 2014 | 17 Pages |
Abstract
The group devised a questionnaire to collect information on the use of recovery animals in general regulatory toxicology studies to support first-in-human studies. Questions focused on study design, the rationale behind inclusion or exclusion and the impact this had on internal and regulatory decisions. Data on 137 compounds (including 53 biologicals and 78 small molecules) from 259 studies showed wide variation in where, when and why recovery animals were included. An analysis of individual study and programme design shows that there are opportunities to reduce the use of recovery animals without impacting drug development.
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Authors
Fiona Sewell, Kathryn Chapman, Paul Baldrick, David Brewster, Alan Broadmeadow, Paul Brown, Leigh Ann Burns-Naas, Janet Clarke, Alex Constan, Jessica Couch, Oliver Czupalla, Andy Danks, Joseph DeGeorge, Lolke de Haan, Klaudia Hettinger, Marilyn Hill,